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Catalog Number 320921 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 10/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that a syringe 0.5ml 29g 12,7mm ema non ce had the cannula protruding through the needle shield which caused two needle sticks before use.The following was reported by the initial reporter" "customer pricked himself in store while the packet of insulin syringes was on the shelf.The needle protruded through the orange cap and went into the customers finger.We have escalated the matter to our head office regarding the injury in store.Customer was very upset and dis-chem pharmacy provided assistance to sent the patient/customer for screening for tb, hiv.Preventative anti-retro-viral treatment provided to customer and case escalated to dis-chem pharmacy group head office.On (b)(6) 2020: as part of the complaint, upon visiting the store to pick up sample on (b)(6) 2020, the responsible pharmacist informed that upon checking the pack that pricked the patient, she picked up a different syringe within the same pack which also pricked her as the needle was protruding out the safety cap.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-30.H6: investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.See h.10.
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Event Description
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It was reported that a syringe 0.5ml 29g 12,7mm ema non ce had the cannula protruding through the needle shield which caused two needle sticks before use.The following was reported by the initial reporter" "customer pricked himself in store while the packet of insulin syringes was on the shelf.The needle protruded through the orange cap and went into the customers finger.We have escalated the matter to our head office regarding the injury in store.Customer was very upset and dis-chem pharmacy provided assistance to sent the patient/customer for screening for tb, hiv.Preventative anti-retro-viral treatment provided to customer and case escalated to dis-chem pharmacy group head office.(b)(6) 2020 :as part of the complaint, upon visiting the store to pick up sample on (b)(6) 2020, the responsible pharmacist informed that upon checking the pack that pricked the patient, she picked up a different syringe within the same pack which also pricked her as the needle was protruding out the safety cap.".
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Search Alerts/Recalls
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